Early Phase Study Of Kesonotide In Participants With Solid Tumours

Study Overview

Early Phase Study of Kesonotide in Participants With Solid Tumours

This clinical trial is an adaptive study of a novel vimentin inhibitor in cancers. It is an open label, multicentre, single ascending dose level in phase I and cohort exploration in phase II. Primary objective is to evaluate safety and tolerability of kesonotide as a monotherapy in participants with advanced/metastatic solid cancers. Secondary objective is to characterise the pharmacokinetics of kesonotide. Phase I study will enrol 20-32 participants and Phase II approximately 80 participants.

This clinical trial is an adaptive phase I/II study of kesonotide, a novel hGIIA-vimentin inhibitor in participants with solid tumours. This is a multicentre, open-label Phase I/II clinical trial. Phase I part of the study is a classic 3+3 dose escalation to identify the Maximum Tolerated Dose, Recommended Phase 2 Dose and Optimal Biological Dose. In the Phase II study, participants will be given one of the two recommended dose levels. This may be as monotherapy or in combination with standard of care. The study treatment will be a 21-day treatment Cycle (once every 3 weeks) and kesonotide will be orally administered. Study treatment will continue until disease progression, loss of clinical benefit, unacceptable toxicity, withdrawal of consent, lost to follow-up or another discontinuation criterion. This trial will utilise an adaptive design which permits treatment arm modification or early stopping for efficacy or futility.

Prostate Cancers
Breast Cancer
Lung Cancers
Ovarian Cancer
Glioblastoma Multiforme (GBM)
Pancreas Cancer
Skin Cancer

DRUG: A novel hGIIA-Vimentin Inhibitor
DRUG: Dose expansion

FLM-CT002

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates	Results Reporting Dates	Study Record Updates
First Submitted 2025-03-20	Results First Submitted N/A	Last Update Submitted that met QC Criteria 2025-04-07
First Submitted that Met QC Criteria 2025-04-07	Results First Submitted that Met QC Criteria N/A	Last Update Posted (ACTUAL) 2025-04-13
First Posted (ACTUAL) 2025-04-13	Results First Posted N/A	Last Verified 2025-04

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

Primary Purpose:
Treatment

Allocation:
Non Randomized

Interventional Model:
Sequential

Masking:
None

Arms and Interventions

Participant Group/Arm	Intervention/Treatment
EXPERIMENTAL: Phase I, Single Arm, dose escalation	DRUG: A novel hGIIA-Vimentin Inhibitor Phase I, dose escalation includes 4 increasing doses, 10mg, 30mg, 60mg and 120mg. DRUG: Dose expansion Phase II will enrol participants in selected indication(s) and will be given one of the two recommended doses by the SMC.
EXPERIMENTAL: 2 Arms of selected indication and recommended dose	DRUG: A novel hGIIA-Vimentin Inhibitor Phase I, dose escalation includes 4 increasing doses, 10mg, 30mg, 60mg and 120mg. DRUG: Dose expansion Phase II will enrol participants in selected indication(s) and will be given one of the two recommended doses by the SMC.

Participant Group/Arm

Intervention/Treatment

EXPERIMENTAL: Phase I, Single Arm, dose escalation

DRUG: A novel hGIIA-Vimentin Inhibitor

Phase I, dose escalation includes 4 increasing doses, 10mg, 30mg, 60mg and 120mg.

DRUG: Dose expansion

Phase II will enrol participants in selected indication(s) and will be given one of the two recommended doses by the SMC.

EXPERIMENTAL: 2 Arms of selected indication and recommended dose

DRUG: A novel hGIIA-Vimentin Inhibitor

Phase I, dose escalation includes 4 increasing doses, 10mg, 30mg, 60mg and 120mg.

DRUG: Dose expansion

Phase II will enrol participants in selected indication(s) and will be given one of the two recommended doses by the SMC.

Primary Outcome Measures	Measure Description	Time Frame
To evaluate the safety and tolerability of kesonotide as a monotherapy in participants with advanced/metastatic solid cancers.	Incidence of serious adverse events (SAEs)	Cycle 1 (21 days)
To evaluate the safety and tolerability of kesonotide as a monotherapy in participants with advanced/metastatic solid cancers.	Treatment emergent adverse effects (TEAEs)	Cycle 1 (21 days)
To evaluate the safety and tolerability of kesonotide as a monotherapy in participants with advanced/metastatic solid cancers.	Incidence and nature of dose-limiting toxicities (DLTs).	Cycle 1 (21 days)
To evaluate the safety and tolerability of kesonotide as a monotherapy in participants with advanced/metastatic solid cancers.	Changes in vital sign measurements (Hear rate in beats per minute, blood pressure in systolic and diastolic mm Hg)	Cycle 1 (21 days)
To evaluate the safety and tolerability of kesonotide as a monotherapy in participants with advanced/metastatic solid cancers.	Clinical safety laboratory parameters (abnormal haematology, clinical chemistry and coagulation blood tests; pregnancy test, as per CTCAE v5.0 classification	Cycle 1 (21 days)
To evaluate the safety and tolerability of kesonotide as a monotherapy in participants with advanced/metastatic solid cancers.	Electrocardiogram (ECG) parameters (Heart Rate, PR Interval, P wave, QRS Complex, T wave, ST Segment, QT Interval)	Cycle 1 (21 days)
To evaluate the safety and tolerability of kesonotide as a monotherapy in participants with advanced/metastatic solid cancers.	Eastern Cooperative Oncology Group (ECOG) performance status findings.	Cycle 1 (21 days)

Secondary Outcome Measures	Measure Description	Time Frame

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Name: Admir Huseincehajic

Phone Number: +61467451064

Email: admir.huseincehajic@filamon.com

Study Contact Backup

Name: Graham Kelly

Phone Number: +61 429 854 390

Email: graham.kelly@filamon.com

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.

Ages Eligible for Study:
ALL

Sexes Eligible for Study:
18 Years

Accepts Healthy Volunteers:

Male or female adults (defined as ≥ 18 years of age or acceptable age according to local regulations at the time of voluntarily signing of informed consent).
Has an ECOG performance status score of 0 or 1.
Has a life expectancy of > 12 weeks in the opinion of the investigator.
Measurable or evaluable disease by CT/MRI according to RECIST v1.1, except for prostate and breast cancer (bone only metastases are acceptable) and glioma.
Histologically or cytologically confirmed locally advanced/metastatic solid cancers.
Has adequate organ function within 7 days prior to Day 1 of Cycle 1, defined as below:
Laboratory Value
Hematology
Platelet count > 100 x 109/L
Hb > 9.0 g/dL
ANC > 1.5 x 109/L
Renal Function
Creatinine < 1.5 x ULN
Hepatic Function
AST and ALT < 3 x ULN for the reference laboratory or < 5 x ULN in the presence of liver metastases
Total bilirubin ≤ 1.5 x ULN
Serum albumin ≥ 2.5 g/dL
INR/PT and APTT ≤ 1.5 x ULN
Male and female participants of reproductive/childbearing potential must agree to use adequate contraceptive methods (e.g., double barrier or intrauterine contraceptive) for at least 90 days during the study and after the last dose of study drug.
Male participants must not freeze or donate sperm starting at screening and throughout the study period, and at least 90 days after the final study drug administration.
Female participants must not donate, or retrieve for their own use, ova from the time of screening and throughout the study treatment period, and at least 90 days after the final study drug administration.
Has failed standard of care or refused next line therapy at the present time and if approved treatment options are still available, can delay approved treatments without harm as judged by the investigator (e.g., patients requesting a break between lines of therapy).

Measurable disease (as defined for Part 1) or recognised and abnormal biomarker levels (e.g., PSA for prostate cancer, CA15.3 for breast cancer).
Defined diseases or disease states of interest, suitable for dose expansion.
Patients who have enrolled in Part 1 of the study (dose-escalation), and in the opinion of the investigator, are benefitting from treatment, may be eligible for Parts 2 and 3.

Participants who are unable to cease any anti-inflammatory medications or statins prior to and during the study, including non-steroidal anti-inflammatories, oral steroids at any dose; topical steroids and anti-inflammatories are allowable.
Participants who have participated in other clinical trials and received investigational products within 4 weeks, or within five half-lives of the treatment, whichever is longer, before Cycle 1 Day 1 of the study period.
Previous adverse reactions which have not returned to Grade 0 or 1 according to NCI-CTCAE v5.0 (except alopecia and fatigue) at the screening visit.
A clinically significant active infection determined by the investigator.
Significant or recurrent third space accumulation (e.g., ascites or pleural effusions) according to the investigator.
Has a medical history of myocardial infraction or unstable angina within 6 months before enrolment.
Has a medical history of symptomatic CHF (New York Heart Association (NYHA) classes II-IV) or serious cardiac arrhythmia requiring treatment.
Has a history or presence of uncontrolled mental illness.
The participant is expected to be non-compliant with critical trial procedures and is not willing or able to adhere to the trial requirements during the study.
Participants are deemed inappropriate for this clinical trial at the discretion of the investigator.

Collaborators and Investigators

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Publications

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